January 2, 2013
Researchers report that Fluzone High-Dose, approved by the US Food and Drug Administration in 2009 for immunizing people 65 and older against the flu, is also effective in building a higher immune response among HIV-infected people. The University of Pennsylvania study compared the immune response of HIV-infected people who received the standard dose of Fluzone with a group of HIV-infected people who took Fluzone High-Dose, said Pablo Tebas, MD. The Fluzone High-Dose group developed more antibodies to the flu and had an immunization response more like healthy younger adults. Tebas noted that others with compromised immune systems -- people with cancer, rheumatoid arthritis, and kidney failure -- might also benefit from Fluzone High-Dose immunization. It was not clear from the results of the study whether people with AIDS (CD4 counts under 200) would receive the same immunization benefit from Fluzone High-Dose.
At present, the FDA has only approved Fluzone High-Dose for use with people 65 and older. It is unlikely that insurance companies would reimburse the use of Fluzone High-Dose with HIV-infected people unless the immunization practices committee of the Centers for Disease Control and Prevention recommends this additional use. There must be a "compelling reason" for CDC to endorse a use other than that approved by FDA, said CDC's Jean Clare Smith, MD. The National Institutes of Health (NIH) -- not the Fluzone High-Dose maker Sanofi Pasteur -- funded the University of Pennsylvania study. Researchers will request that CDC review the study and recommend the use of Fluzone High-Dose with HIV-infected people.
The full report, "Improved Immunogenicity with High-Dose Seasonal Influenza Vaccine in HIV-Infected Persons: A Single-Center, Parallel, Randomized Trial," was published in the journal Annals of Internal Medicine (2013; 158(1):19-26).